EmergenciesOHIBEMNCT05424497
Outcome, Hindsight and Implicit Bias in Emergency Medicine and Medical Disciplinary Law.
An observational study of Emergencies and Implicit Bias, run by Maxima Medical Center.
Trial summary
Background Hindsight bias and outcome bias may play an important role in retrospective law of errors in Emergency Medicine and may affect judgement. In addition, differences in sex and medical history may affect treatment decisions (implicit bias). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Emergencies, Implicit Bias
- What is being tested?
- Vignettes
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency physicians selected through email plus physicians with experience in disciplinary law.
Who may be able to join
- Emergency physicians or residents, General practitioners, and physicians with experience in disciplinary law.
Who cannot join
- others
About this study
Background Hindsight bias and outcome bias may play an important role in retrospective law of errors in Emergency Medicine and may affect judgement. In addition, differences in sex and medical history may affect treatment decisions (implicit bias).
Aims First, to assess if and to what extent knowledge of an outcome may affect the ability of Emergency Physicians and physicians with experience in disciplinary law to determine the quality of care given. Secondly, to investigate whether a medical history with nonspecific/functional/somatoform complaints and sex differences affect clinical decision making in Emergency Physicians.
Read more
Study design and analyses A web-based cross-sectional survey using vignettes with six clinical scenarios (four vignettes for outcome/hindsight bias, four vignettes for implicit bias). The survey was sent to all Emergency Physicians and residents in training in the Netherlands. Four scenarios were also sent to physicians with experience in disciplinary law. In four vignettes, participants received a scenario without an outcome, or with a positive or negative outcome. They were asked to rate the quality of care provided as sufficient or insufficient and, in more detail, poor/below average/average/good/outstanding and how likely they thought it would be that the patient would have had a negative outcome (in percent). In the other two vignettes, participants received one vignette describing a scenario of a patient presenting to the ED with acute abdominal pain and one vignette describing a scenario with chest pain. The sex and medical history differed among the participants (e.g. male/female, nonspecific medical history/somatic medical history). Participants were asked whether they would prescribe pain medication, and whether they would do diagnostic imaging.
Importance and impact This research may help to understand the impact of knowing the outcome in retrospective laws in Dutch Emergency Physicians and physicians with experience in disciplinary law. If outcome and hindsight bias are present, retrospective judgement may need a different approach in medicine, i.e. blinding judges for the outcome, to prevent wrong justice and adverse effect on clinicians well-being. Also, if implicit bias in sex and medical history is present, a training programme is needed to reduce certain bias and to improve equality in the provided care.
- Conditions
- Emergencies, Implicit Bias
- Being tested
- Vignettes
- Medical subject headings
- Emergencies, Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VignettesOther
Presenting vignettes with fictive cases
| Study group | Role | What they receive |
|---|---|---|
| No outcome provided | Not described Receives: Other: Vignettes | |
| outcome positive | Not described Receives: Other: Vignettes | |
| outcome negative | Not described Receives: Other: Vignettes | |
| implicit bias group | Not described Receives: Other: Vignettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care
The quality of care rated on a likert scale from 1 to 5 will be assessed for 4 fictive cases. The mean will be compared for each case without outcome, with positive outcome, and with negative outcome.
Measured: Throughout the study, 1day
Diagnostic imaging
Whether the physician would perform diagnostic imaging after reading the vignette. The The outcome will be compared for vignettes including a somatic medical history with the vignettes with a nonsomatic medical history.
Measured: Throughout the study, 1day
Secondary outcomes (2)
Hindsight bias
The estimate of the chance of getting the negative outcome (0 to 100%). Compared between the group of vignettes without outcome, with a positive outcome and with a negative outcome.
Measured: Throughout the study, 1day
Pain medication
Whether pain medication is prescribed (y/n) and how many milligrams. Compared between group of patients with somatic medical history and nonsomatic medical history.
Measured: Throughout the study, 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start16 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Candel, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424497
- Sponsor's protocol ID
- N22.025
- Acronym
- OHIBEM
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome, Hindsight and Implicit Bias in Emergency Medicine and Medical Disciplinary Law.
- ClinicalTrials.gov ID
- NCT05424497
- Acronym / sponsor ID
- OHIBEM / N22.025
- Conditions
- Emergencies, Implicit Bias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 16 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Hindsight bias and outcome bias may play an important role in retrospective law of errors in Emergency Medicine and may affect judgement. In addition, differences in sex and medical history may affect treatment decisions (implicit bias).
Aims First, to assess if and to what extent knowledge of an outcome may affect the ability of Emergency Physicians and physicians with experience in disciplinary law to determine the quality of care given. Secondly, to investigate whether a medical history with nonspecific/functional/somatoform complaints and sex differences affect clinical decision making in Emergency Physicians.
Study design and analyses A web-based cross-sectional survey using vignettes with six clinical scenarios (four vignettes for outcome/hindsight bias, four vignettes for implicit bias). The survey was sent to all Emergency Physicians and residents in training in the Netherlands. Four scenarios were also sent to physicians with experience in disciplinary law. In four vignettes, participants received a scenario without an outcome, or with a positive or negative outcome. They were asked to rate the quality of care provided as sufficient or insufficient and, in more detail, poor/below average/average/good/outstanding and how likely they thought it would be that the patient would have had a negative outcome (in percent). In the other two vignettes, participants received one vignette describing a scenario of a patient presenting to the ED with acute abdominal pain and one vignette describing a scenario with chest pain. The sex and medical history differed among the participants (e.g. male/female, nonspecific medical history/somatic medical history). Participants were asked whether they would prescribe pain medication, and whether they would do diagnostic imaging.
Importance and impact This research may help to understand the impact of knowing the outcome in retrospective laws in Dutch Emergency Physicians and physicians with experience in disciplinary law. If outcome and hindsight bias are present, retrospective judgement may need a different approach in medicine, i.e. blinding judges for the outcome, to prevent wrong justice and adverse effect on clinicians well-being. Also, if implicit bias in sex and medical history is present, a training programme is needed to reduce certain bias and to improve equality in the provided care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No outcome provided | – | Other: Vignettes |
| outcome positive | – | Other: Vignettes |
| outcome negative | – | Other: Vignettes |
| implicit bias group | – | Other: Vignettes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency physicians selected through email plus physicians with experience in disciplinary law.
Key inclusion criteria (1 listed)
- Emergency physicians or residents, General practitioners, and physicians with experience in disciplinary law.
Key exclusion criteria (1 listed)
- others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VignettesPresenting vignettes with fictive cases | Other | No outcome provided, implicit bias group, outcome negative, outcome positive |
Primary outcome
Quality of care
Time frame: Throughout the study, 1day
The quality of care rated on a likert scale from 1 to 5 will be assessed for 4 fictive cases. The mean will be compared for each case without outcome, with positive outcome, and with negative outcome.
Diagnostic imaging
Time frame: Throughout the study, 1day
Whether the physician would perform diagnostic imaging after reading the vignette. The The outcome will be compared for vignettes including a somatic medical history with the vignettes with a nonsomatic medical history.
2 secondary outcomes
Hindsight bias
Time frame: Throughout the study, 1day
Pain medication
Time frame: Throughout the study, 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Implicit Bias, run by Maxima Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of care (time frame: Throughout the study, 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.